A Drug-drug Interaction (DDI) Study to Assess the Effect of INC280 on the Pharmacokinetics of Digoxin and Rosuvastatin in Patients With cMET-dysregulated Advanced Solid Tumors
NCT ID: NCT02626234
Last Updated: 2020-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2015-12-08
2017-04-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
INC280
INC280
digoxin
rosuvastatin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
INC280
digoxin
rosuvastatin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* advanced solid tumors and have confirmed cMET dysregulation
* at least one measurable lesion as defined by RECIST 1.1.
* recovered from all toxicities related to prior anti-cancer therapies
* adequate organ function
* ECOG performance status (PS) of 0 or 1
Exclusion Criteria
* known hypersensitivity to any of the excipients of INC280
* prior treatment with cMET or HGF-targeting inhibitor
* known hypersensitivity to digoxin or rosuvastatin or its excipients
* symptomatic central nervous system (CNS) metastases who are neurologically unstable
* presence or history of carcinomatous meningitis
* history of another primary malignancy that is currently clinically significant or currently requires active intervention
* Clinically significant, uncontrolled heart diseases, including QTcF ≥ 450 msec (male patients), ≥ 460 msec (female patients) on the screening ECG
* Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting INC280
* Major surgery within 4 weeks prior to starting INC280
* Patients receiving unstable or increasing doses of corticosteroids.
* Impairment of GI function or GI disease that may significantly alter the absorption of INC280
* Patients who have received, or are expected to receive digoxin or rosuvastatin within 21 days prior to the beginning of the DDI phase (Day 1) and for the duration of the DDI phase.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Emory University School of Medicine/Winship Cancer Institute Phase 1 Working Group
Atlanta, Georgia, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Novartis Investigative Site
Vienna, , Austria
Novartis Investigative Site
Edegem, Antwerpen, Belgium
Novartis Investigative Site
Brno, , Czechia
Novartis Investigative Site
Ioannina, GR, Greece
Novartis Investigative Site
Athens, , Greece
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Candiolo, TO, Italy
Novartis Investigative Site
Bologna, , Italy
Novartis Investigative Site
Napoli, , Italy
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Results for CINC280A2105 can be found Novartis Clinical trials results website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CINC280A2105
Identifier Type: -
Identifier Source: org_study_id